FDA approval for Alzheimer’s disease treatment is a ‘monumental step forward’

An advocacy organization is celebrating the U.S. Food and Drug Administration’s decision to grant the approval of a disease-modifying therapy for Alzheimer’s disease.

The news is a historic step forward for people living with Alzheimer’s and their families, who now finally have treatment that can slow the onset of the disease, extend independence and improve quality of life, according to Voices of Alzheimer’s, an organization led by people with lived experience with Alzheimer’s.

Leqembi initially received accelerated approval from the FDA in January after clinical trial research showed a slowing of cognitive and functional decline for people with mild cognitive impairment at the early stage of the disease.

After decades of failed attempts at developing treatments, Leqembi’s traditional approval represents hope for millions across the country affected by Alzheimer’s disease.

Voices of Alzheimer’s said it will continue to fight to ensure that people living with Alzheimer’s have affordable access to the diagnostics and treatments necessary to combat this disease.

Voices of Alzheimer’s is monitoring the ongoing position of Centers for Medicare and Medicaid Services thus far claiming to provide broad access to Leqembi through Medicare now that the treatment has received FDA traditional approval. The organization vows to hold the agency to its promise to ensure that any Medicare beneficiary medically eligible for Leqembi can access the treatment.

Voices of Alzheimer’s members will also continue to press Medicare to ensure it keeps its word in ensuring that its registry requirements are not burdensome to patients and do not hinder access to treatment. Immediate, no-cost access to the registry, accessible reporting and prescribing requirements, and no exclusion of specific subgroups from receiving the medication appear to be positive steps forward.

It also remains true that Medicare should never have required a registry for Leqembi in the first place, as CMS has never before required a registry for a traditionally approved treatment or issued a National Coverage Determination for an entire class of drugs, according to the organization.

The FDA’s rigorous approval process ensures that by the time CMS makes a coverage determination, evidence for the on-label use of a drug is proven. No matter how it is implemented, a registry is unnecessary and sets a dangerous precedent for access to future treatments for Alzheimer’s and all other conditions, said the advocacy group.

“The decision by the FDA to grant traditional approval for Leqembi is a monumental step forward for the Alzheimer’s community,” said Jim Taylor, President of Voices of Alzheimer’s and a long-time care partner. “For so long, people living with the condition have been left hopeless, with no options for treatment. This approval is a hard-fought victory for millions of people living with Alzheimer’s and their families, who now have hope that we are moving toward a future free from this terrible disease.”